Tonix plans adaptive Phase 2 trial of TNX-4800 antibody to prevent Lyme disease, targets Q1 2027 start - TNXP News | RalliesTonix plans adaptive Phase 2 trial of TNX-4800 antibody to prevent Lyme disease, targets Q1 2027 start
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TNXP• Tonix outlines adaptive Phase 2 Lyme disease prevention study
- Tonix received FDA Type C meeting minutes supporting plans for an adaptive Phase 2 field study of TNX-4800 to prevent Lyme disease.
- No clinical results were presented; the Phase 2 study is planned to start in Q1 2027, pending final protocol clearance.
- Trial design aligns on a randomized, placebo-controlled study of about 3,300 adults over two Lyme seasons.
- Study aims to show whether the long-acting antibody can prevent Lyme disease across the season, with safety tracked for 52 weeks.
- Most enrollment is expected in the 2028 season; enrollment could extend into 2029 if Lyme incidence runs below expectations.
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